Cancer-related Problem/Condition, Neurotoxicity, Pain, Peripheral Neuropathy
Conditions
Brief summary
RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer.
Detailed description
OBJECTIVES: I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time. II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate the effect of MC5-A on daily opioid and other pain medication use. OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. After completion of study treatment, patients are followed up for 3 months.
Interventions
OTHERelectrical stimulation pain therapy
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
OTHERquestionnaire administration
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CIPN neuropathy: received, or currently receiving, neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib) * Pain or symptoms of peripheral neuropathy of \>= 1 months duration attributed to chemotherapy-induced peripheral neuropathy * OR pain of the other types including chemotherapy-induced peripheral neuropathy, numbness predominant; post mastectomy pain; post surgical pain; post herpetic neuropathy; post radiation pain; other (vertebral compression, fracture, miscellaneous) * The pain must have been stable for at least 2 weeks * An average daily pain rating of \>= 5 out of 10, using the pain numerical rating scale (NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the patient at least a little bit on the CIPN-20 * Life expectancy \>= 3 months * ECOG performance status 0, 1, or 2
Exclusion criteria
* Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, abstinence, etc.) * Use of an investigational agent for pain control concurrently or =\< 30 days * History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation * Patients with implantable drug delivery systems, e.g., Medtronic Synchromed * Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates (metal implants for orthopedic repair, e.g., pins, clips, plates, cages, joint replacements are allowed) * Patients with a history of myocardial infarction or ischemic heart disease within the past six months * Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases * Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks * Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy) * Skin conditions such as open sores that would prevent proper application of the electrodes * Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score From Day 1 to Day 10 | From day 1 to day 10 | Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics | From day 1 to day 30 | Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most |
| Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 | Day 10 | Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst. |
| Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 | Day 1 | Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst. |
| Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 | month 2 | Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst. |
| Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 | Month 3 | Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst. |
| Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 | month 1 | Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical
Pre-assignment details
No pre-assignment criteria
Participants by arm
| Arm | Count |
|---|---|
| MC5A Calmare Therapy Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | MC5A Calmare Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 0.7 |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
Primary
Change in Pain Score From Day 1 to Day 10
Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)
Time frame: From day 1 to day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I | Change in Pain Score From Day 1 to Day 10 | -3.3 units on a scale | Standard Deviation 0.7 |
Secondary
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time frame: Day 1
Population: Participants at Day 1
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I | Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 | sensory symptoms | 20.4129 units on a scale | Standard Error 0.9114 |
| Arm I | Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 | motor symptoms | 15.6268 units on a scale | Standard Error 0.7598 |
Secondary
Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2
Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time frame: month 2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I | Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 | sensory symptoms | 16.4723 units on a scale | Standard Error 0.948 |
| Arm I | Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 | motor symptoms | 13.3816 units on a scale | Standard Error 0.7917 |
Secondary
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10
Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time frame: Day 10
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 | sensory symptoms | 17.8305 units on a scale | Standard Error 0.9437 |
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 | motor symptoms | 14.1815 units on a scale | Standard Error 0.7878 |
Secondary
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1
Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time frame: month 1
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 | snesory symptoms | 16.5207 units on a scale | Standard Error 0.9345 |
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 | motor symptoms | 13.5443 units on a scale | Standard Error 0.7797 |
Secondary
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3
Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time frame: Month 3
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 | sensory symptoms | 17.3325 units on a scale | Standard Error 0.9388 |
| Arm I | Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 | motor symptoms | 12.8499 units on a scale | Standard Error 0.7835 |
Secondary
Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most
Time frame: From day 1 to day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I | Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics | 28.9 doses | Standard Deviation 47.3 |